Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

ACL rupture has a high morbidity in productive-age population. The increasing incidence and proper management has become a point of interest in the musculoskeletal sport injury. Choosing the best graft has become the main focus in searching for a better outcome regarding ACL reconstruction in these patient population. Currently, single bundle hamstring tendon (SBHT) autograft was preferred in Asian population compared to bone quadriceps tendon (BQT) autograft. However, there are some problems such as smaller size, as well as diameter, of SBHT. This study is focused on evaluation of the clinical outcome between BQT and SBHT in arthroscopic-assisted ACL reconstruction patients.

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Key information

Conditions

Sports Injury Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Athletic Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In this prospective cohort study, 30 subjects were divided into 2 groups (BQT and SBHT). Sampling was taken between February 2016-2017 (1 year) in one orthopaedic center. The instruments used for evaluation are rolimeter and PRO questionnaires (IKDC, Tegner-Lysholm, and KOOS) with data mining between 1 month, 3 months, and 6 months post operation.

To obtain a valid and accountable research data, the investigators collected the information based on 2 parameters and then crosschecked the results.

After clinical data was obtained, the investigators translate the results into a statistical data using SPSS ver.24 and simplified the data for national registry and academic purposes.

According to previous studies, and research hypothesis, functional outcome of patient undergoing arthroscopic-assisted ACL reconstruction is better in BQT group compared to SBHT group, both in subjective and objective parameters given.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Unilateral, total rupture of ACL
Procedure performed by the same surgeon
Age of subjects between 15-40 years old

Exclusion criteria

Multiligamentous injury
Bilateral ACL ruptures
Ligamentous laxity
Prior knee ligamentous surgery

Treatment and study plan

Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction

Procedure

New intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment

Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction

Procedure

Comparator for New Reconstruction Technique

Primary outcomes

Changes (Improvement) of Rolimeter Measurement After Procedure

Time frame: Measurement in 1 year after operation
- Rolimeter measurement is the objective outcome expected in this study
- This device was calibrated and tested prior to the usage in the study
- Literature review --> no significant difference between KT1000/2000 and rolimeter for measuring antero-posterior translation of the knee joint
Changes (Improvement) of PRO Questionnaire After Procedure

Time frame: PRO was taken in a period of 1 year after surgical procedure
- We use three different PRO to make an accountable subjective outcome
- No standard PRO questionnaire for ACL cases; we used three to be able to triangulate the mean subjective outcome
- Rationale for using three PRO : these PROs were rapidly used in other similar studies around the world, had good and reliable results, and contains categoric and numeric data for statistical computation and interpretation

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison of Functional Outcome Between Bone Quadriceps Tendon (BQT) and Single-Bundle Hamstring Tendon (SBHT) Autograft in Arthroscopic-assissted Anterior Cruciate Ligament Reconstruction: a Prospective Cohort Study

Acronym: BQTSBHTFMUI

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Sep 2, 2020
Registry last updated: Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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